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Incentivizing Buprenorphine-Naloxone Initiation in Emergency Departments

Primary Purpose

Opioid Use

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Training
Behavioral economic enhanced arm
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Opioid Use

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Residents and Advanced Practice Providers and attending clinicians working in emergency departments in Pennsylvania.

Exclusion Criteria:

-

Sites / Locations

  • University of Pennsylvania Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Standard training arm

Behavioral economic enhanced arm

Arm Description

The standard training arm will consist of (1) in-person training with pre- and post-session knowledge and attitude assessment, (2) three month post-session knowledge and attitude assessment and (3) self-report of first-time buprenorphine-naloxone Emergency Department administration within 3 month study period.

The behavioral economic enhanced training arm will consist of (1) in-person training with pre- and post-session knowledge and attitude assessment, (2) three month post-session knowledge and attitude assessment and (3) self-report of first-time buprenorphine-naloxone Emergency Department administration within 3 month study period in addition to an opt-out invitation, loss-framed incentivization, and weekly tailored text message-based reminders

Outcomes

Primary Outcome Measures

Change in Emergency Department initiated buprenorphine-naloxone treatment
Measuring number of providers who have initiated at least one first dose of buprenorphine-naloxone

Secondary Outcome Measures

Training Attendance
Measure the number of clinicians who attend the training with the incentive.
Change in attitude about buprenorphine-naloxone Questionaire
The scale is not a validated tool. It is a construct to measure attitudes about buprenorphine-naloxone. It is a Likert scale 1-5, 1 being strongly disagree and 5 being strongly agree. Higher values signify more favorable outcomes.

Full Information

First Posted
January 25, 2019
Last Updated
March 16, 2020
Sponsor
University of Pennsylvania
Collaborators
American College of Medical Toxicology, Blue Cross Blue Shield
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1. Study Identification

Unique Protocol Identification Number
NCT03821103
Brief Title
Incentivizing Buprenorphine-Naloxone Initiation in Emergency Departments
Official Title
Incentivizing Buprenorphine-Naloxone Initiation in Emergency Departments
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
February 6, 2019 (Actual)
Primary Completion Date
January 31, 2020 (Actual)
Study Completion Date
February 29, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
American College of Medical Toxicology, Blue Cross Blue Shield

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study seeks to test standard and behavioral economic-enhanced training strategies to bolster first-time Emergency Department-initiated buprenorphine-naloxone administration among Emergency Department providers.
Detailed Description
Philadelphia is experiencing a significant opioid crisis. Through this novel pilot study, critical training about opioid use disorder and medication-assisted treatment with buprenorphine-naloxone will be provided to emergency providers and changes in clinical practice will be incentivized in order to optimize treatment engagement for patients with opioid use disorder in the Emergency Department. Participants will be invited to participate in a brief in-person training session, will receive a pre- and post-session knowledge and attitude assessment, and will be invited to self-report first-time buprenorphine-naloxone Emergency Department administration within the 3 month study period. Participants will be randomized to one of two arms: standard training arm and behavioral economic enhanced arm. The standard training arm will receive the aforementioned intervention. The behavioral economic enhanced arm will additionally receive an opt-out invitation, loss-framed incentivization, and weekly tailored text message-based reminders. Endpoints of interest include retained knowledge and change in provider attitudes regarding Emergency department buprenorphine-naloxone administration and treatment following training and again at 3 months, and first-time Emergency department administration of buprenorphine-naloxone.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard training arm
Arm Type
Experimental
Arm Description
The standard training arm will consist of (1) in-person training with pre- and post-session knowledge and attitude assessment, (2) three month post-session knowledge and attitude assessment and (3) self-report of first-time buprenorphine-naloxone Emergency Department administration within 3 month study period.
Arm Title
Behavioral economic enhanced arm
Arm Type
Experimental
Arm Description
The behavioral economic enhanced training arm will consist of (1) in-person training with pre- and post-session knowledge and attitude assessment, (2) three month post-session knowledge and attitude assessment and (3) self-report of first-time buprenorphine-naloxone Emergency Department administration within 3 month study period in addition to an opt-out invitation, loss-framed incentivization, and weekly tailored text message-based reminders
Intervention Type
Behavioral
Intervention Name(s)
Training
Intervention Description
The training includes of (1) in-person training with pre- and post-session knowledge and attitude assessment, (2) three month post-session knowledge and attitude assessment and (3) self-report of first-time buprenorphine-naloxone Emergency Department (ED) administration within 3 month study period
Intervention Type
Behavioral
Intervention Name(s)
Behavioral economic enhanced arm
Intervention Description
Behavioral economic enhancement includes an opt-out invitation, loss-framed incentivization, weekly tailored text based reminders
Primary Outcome Measure Information:
Title
Change in Emergency Department initiated buprenorphine-naloxone treatment
Description
Measuring number of providers who have initiated at least one first dose of buprenorphine-naloxone
Time Frame
One year
Secondary Outcome Measure Information:
Title
Training Attendance
Description
Measure the number of clinicians who attend the training with the incentive.
Time Frame
First week
Title
Change in attitude about buprenorphine-naloxone Questionaire
Description
The scale is not a validated tool. It is a construct to measure attitudes about buprenorphine-naloxone. It is a Likert scale 1-5, 1 being strongly disagree and 5 being strongly agree. Higher values signify more favorable outcomes.
Time Frame
Three months
Other Pre-specified Outcome Measures:
Title
Retained knowledge of buprenorphine-naloxone treatment Questionaire
Description
Compare retention of knowledge and assessment from before and after the training in the two arms.The scale is not a validated tool. It is a construct of questions to measure retained knowledge about buprenorphine-naloxone initiation. The scale is a percentage of questions answered correctly. Minimum score is 0% and maximum score is 100%. Higher values signify more favorable outcomes.
Time Frame
Three months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Residents and Advanced Practice Providers and attending clinicians working in emergency departments in Pennsylvania. Exclusion Criteria: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeanmarie Perrone, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania Health System
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35415804
Citation
Khatri UG, Lee K, Lin T, D'Orazio JL, Patel MS, Shofer FS, Perrone J. A Brief Educational Intervention to Increase ED Initiation of Buprenorphine for Opioid Use Disorder (OUD). J Med Toxicol. 2022 Jul;18(3):205-213. doi: 10.1007/s13181-022-00890-7. Epub 2022 Apr 12.
Results Reference
derived

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Incentivizing Buprenorphine-Naloxone Initiation in Emergency Departments

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